Large scale safety study of ketoprofen 25 mg (Toprec®) in febrile and painful conditions

Pharmacoepidemiology and Drug Safety

Volumn 5, Issue 5, 1996, Pages 295-302

  Moore, Nicholas ^a   Vuillemin, Nicole ^b   Abiteboul, Michel ^c   Boudignat, Odile ^d   Paliwoda, André ^e   Robin, Jean Louis ^c   Jacobs, Laurent Didier ^c  

^a ROUEN UNIVERSITY HOSPITAL   (France)

^b Pasteur Hospital   (France)

^c SANOFI   (France)

^d Laboratoires Bellon   (France)

^e SA Le Kremlin Bicetre   (France)

Author keywords

Adverse events; Analgesics; Ketoprofen; NSAIDS; Postmarketing cohort study; Risk factors

Indexed keywords

KETOPROFEN;

ADOLESCENT; ADULT; AGED; ANALGESIA; ARTICLE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSMENORRHEA; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MALE; MYALGIA; ORAL DRUG ADMINISTRATION; PAIN; PRIORITY JOURNAL; SELF MEDICATION;

EID: 0029904827     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1099-1557(199609)5:5<295::AID-PDS233>3.0.CO;2-0     Document Type: Article

References (14)

1. Mehlisch, D. Double-blind crossover comparison of ketoprofen, naproxen, and placebo in patients with primary dysmenorrhea. Clinical Therapeutics 1990; 12: 398-409.
2. Bradley, J., Brandt, K., Katz, B., Kalasinski, L. and Ryan, S. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patient with osteoarthritis of the knee. New England Journal of Medicine 1991; 325: 87-91.
3. Aabakken, L. Review article: non-steroidal antiinflammatory drugs - the extending scope of gastrointestinal side-effects. Alimentary Pharmacology and Therapeutics 1992; 6: 143-162.
4. Meckstroth, S., Schwartz, M. and Agrawal, N. NSAIDs: safety implications of over-the-counter availability. Drug Safety 1992; 7: 241-244.
5. Waller, P., Wood, S., Langman, M., Breckenridge, A. and Rawlins, M. Review of postmarketing surveillance studies. British Medical Journal 1992; 304: 1470-1472.
6. Spilker, B. Guide to Clinical Trials. Raven Press, New York, 1992.
7. Savage, R., Moller, P., Ballantyne, C. and Wells, J. Variation in the risk of peptic ulcer complications with nonsteroidal antiinflammatory drug therapy. Arthritis and Rheumatism 1993; 36: 84-90.
8. Haase, W. and Fischer, M. Statistische Metaanalyse von multizentrischen klinischen Studien mit Ibuprofen im Hinblick auf die Kohortengröße. Zeitschrift für Rheumatologie 1991; 50: 77-83.
9. Laporte, J., Carne, X., Vidal, X., Moreno, V. and Juan, J. Upper gastro-intestinal bleeding in relation to previous use of analgesics and non-steroidal antiinflammatory drugs. Lancet 1991; 337: 85-89.
10. Henry, D., Dobson, A. and Turner, C. Variability in the risk of major gastro-intestinal complications from nonaspirin non steroidal antiinflammatory drugs. Gastroenterology 1993; 105: 1078-1088.
11. Garcia, L. and Jick, H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994; 343: 769-772.
12. Langman, M., Weil, J., Wainwright, P., et al. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994; 343: 1075-1078.
13. Kaufman, D., Kelly, J., Sheehan, J., et al. Non-steroidal anti-inflammatory drug use in relation to major upper gastro-intestinal bleeding. Clinical Pharmacology and Therapeutics 1993; 53: 485-494.
14. Bégaud, B., Chaslerie, A., Carne, X., et al. Upper gastrointestinal bleeding associated with analgesics and NSAID use: a case-control study. Journal of Rheumatology 1993; 20: 1444-1445.